Associate Pharmacovigilance Project Director (Delivery)- Europe

Job Description

• Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered
• within budget, and are on time with good quality and in compliance with the applicable regulatory requirements.
• Support project teams as PV expert on all contracted activities performed on behalf of PrimeVigilance clients, as necessary.
• Providing support to Head of PM department, Head of PV Operations and senior leadership management, as applicable, in other activities undertaken on behalf of the client and thecompany.
• Together with direct reports representing the client's and PrimeVigilance interests with the aimof keeping the agreed project scope
• Oversee management of changes to the project scope, project schedule and project costs, as applicable
• Maintaining good client relations and ensuring a consistently high quality of work for each client
• Being involved in issue escalation process
• Understand client PV requirements and ensure service provided addresses all requirements
• Overseeing and monitoring Project set-up and maintenance activities planning; attending client meetings, as required
• Having an overview of deliverables to the clients
• Being involved in tasks to be delivered to the client, as applicable
• Oversight on all issues communication with clients
• Overseeing training of project teams
• Close cooperation with other PrimeVigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines
• Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
• Review of client specific core documents (e.g. Joint operational guidelines, Safety management plan,…), as applicable
• Making sure invoices are prepared and sent on time
• Review project specific analysis, as needed
• Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
• Providing the client with appropriate qualified resources to ensure their project is managed and handled effectively
• Overseeing the management of Quality Management System activities for the client, as required
• Making sure that quality standards applicable to the respective client are met
• Ensuring compliance with worldwide PV regulatory obligations; manage the process for Quality Events (QEs) and implement corrective and preventative action (CAPA).
• Participation in client audits and inspections

Qualifications

Requirements:

• Excellent client-facing and internal communication (written and verbal) skills
• Varied PV experience in a CRO
• Previous experience within PV Project Management
• Organization skills, including attention to detail and multitasking
• Management skills, including time and issue management
• Conflict resolution skills
• Decision making
• Team working
• Ability to motivate/coach people; leadership

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.

• Integrity and trust: we do the right thing, especially when it is hard.

• Drive and passion: we care about the outcome, because someone is waiting on it.

• Agility and responsiveness: we move quickly, because patients cannot wait.

• Belonging: everyone is welcome, and every voice counts.

• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.